Description

Enurace Tablets are given to bitches which have been spayed (neutered or ovariohysterectomised). Enurace acts to tighten up the muscles near the exit to the bladder and is used to treat urinary incontinence. It has been found that some spayed bitches start to leak urine when completely relaxed. This can start at any time after spaying, sometimes years later. Enurace tablets are normally given twice daily for life at the lowest effective dose.

Uses

Dosage and administration

A starting dose of 2 mg Ephedrine HCl per kg of bodyweight per day, divided in two oral doses is recommended. Dogs can be dosed according to the following table:

Weight

(kg)

Dose

(mg/day)

Dose (number of tablets)

per day

1st

2nd

5

10

1

½

½

7.5

15

1 ½

½

1

10

20

2

1

1

12.5

25

2½

1

1 ½

15

30

3

1 ½

1 ½

17.5

35

3½

1 ½

2

For weights of 20 kg or above use Enurace 50

Desired therapeutic effect and occurrence of adverse effects have to be monitored approximately at 14 days, 1 month, 3 months and 6 months after the start. Based on the observed effect in comparison with the expected effect and taking into account the occurrence of adverse effects, the individual dose should be adjusted. The dose should be adjusted to find the lowest effective dose.

Once the effective dose has been established, dogs should still be monitored at regular intervals, e.g. every six months.

The product should be administered before meals in a piece of food.

A maximum dose of 5 mg/ kg of bodyweight per day has to be respected.

Contra-indications, warnings, etc

Do not use in dogs with glaucoma

Do not use in case of hypersensitivity to Ephedrine or to any of the excipients.

Do not use in dogs under 5 kg of body weight.

This product is not suitable for treatment of inappropriate urination resulting from behaviour problems.

As ephedrine is an alpha and beta adrenergic receptor agonist, the product should be used with caution in dogs with cardiovascular disease and only after a comprehensive risk/benefit analysis by the attending veterinarian.

The dog’s cardiovascular functionality should be carefully assessed before the start of the treatment with the product and it should be periodically monitored during the treatment.

In addition, a similar approach should be adopted in animals suffering from partial urethral obstruction, hypertension, diabetes mellitus, hyperadrenocorticism, hyperthyroidism or other metabolic disorders. It should be mentioned that the Polyuria/Polydipsia (PU/PD) frequently accompanying the aforementioned conditions may be falsely diagnosed as urinary incontinence.

Adverse reactions

Cardiovascular effects like tachycardia, atrial fibrillation, stimulation of the heart activity and vasoconstriction.

Stimulation of the central nervous system leading to sleeplessness, excitation, anxiety and muscle tremors.

Panting

Mydriasis

Cystitis

Bronchodilatation and decrease of mucus release in the respiratory mucosal membranes.

Reduction of the motility and tone of the intestinal wall.

Due to the nature of Ephedrine the mentioned effects can occur at the recommended therapeutic dose, with anxiety and cardiovascular effects being the most prevalent. In efficacy studies, side effects have been observed in 10% of the treatments.

Operator warnings

Ephedrine hydrochloride could be toxic if ingested. Adverse effects may include insomnia and nervousness, dizziness, headache, increased blood pressure, increased sweating and nausea.

Ingestion may be fatal, especially in children. To avoid accidental ingestion, the product must be used and kept out of the reach of children. Always replace the cap securely after use.

In the event of accidental ingestion, most importantly by children, seek immediate medical attention showing the physician the package insert.

It is strongly recommended that pregnant women should wear gloves for administration.

Wash hands after administration.

Use during pregnancy, lactation or lay

The safety of the product has not been established during pregnancy and lactation.

Do not use during the pregnancy and lactation.

Do not use in breeding animals.

Interactions

Ephedrine may interact with other sympathomimetics.

Ephedrine may enhance glucocorticoid metabolism.

Concomitant use with MAO-inhibitors may cause hypertension.

Ephedrine can enhance the activity of products of the same class as Theophylline.

Volatile anaesthetics may enhance the sensitivity of the myocardium to the cardiovascular effects of Ephedrine.

Concomitant use with cardiac glycosides, Quinine and tricyclic antidepressants can cause arrhythmias.

Vascular constrictions can occur after concomitant treatment with ergot alkaloids and Oxytocin.

Substances leading to an increase in pH of the urine are able to prolong the excretion of ephedrine, whereas substances leading to a decrease in pH of the urine are able to accelerate the excretion of ephedrine.

Overdose

The signs of overdose resemble those of the adverse reactions as described above. In case of overdose, it is useful to accelerate excretion of ephedrine by acidification of the urine and enhanced diuresis.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

Do not store above 25 °C.

Store in the original container. Divided tablets should be returned to the original package and used in the subsequent dose. Close the cap to click.

Legal category

POM-V

Packaging Quantities

Further information

Ephedrine directly stimulates alpha- and beta-adrenergic receptors, present in all organ systems. It also stimulates the release of catecholamines from sympathetic neurons. Since Ephedrine passes the blood-brain barrier, it also induces effects that are mediated through the central nervous system.

Ephedrine specifically causes a contraction of the internal urethral sphincter muscles and a relaxation of the bladder muscles through a sympathicomimetic action on the adrenergic receptors.

Marketing Authorisation Holder (if different from distributor)

Ecuphar NV

Legeweg 157-I

8020 Oostkamp

Belgium

Marketing authorisation number

Vm 32742/4001.

GTIN (Global Trade Item No)

-

Enurace 50, 50 mg Tablets for Dogs

Presentation

Tablets: Round, white tablet with break line on one side and inscription ENURACE 50 on the other side.

Uses

Dosage and administration

A starting dose of 2 mg Ephedrine HCl per kg of bodyweight per day, divided in two oral doses is recommended. Dogs can be dosed according to the following table:

Weight

(kg)

Dose

(mg/day)

Dose (number of tablets)

per day

1st

2nd

20-30

50

1

½

½

31-40

75

1 ½

½

1

41-50

100

2

1

1

Desired therapeutic effect and occurrence of adverse effects have to be monitored approximately at 14 days, 1 month, 3 months and 6 months after the start. Based on the observed effect in comparison with the expected effect and taking into account the occurrence of adverse effects, the individual dose should be adjusted. The dose should be adjusted to find the lowest effective dose.

Once the effective dose has been established, dogs should still be monitored at regular intervals, e.g. every six months.

The product should be administered before meals in a piece of food.

A maximum dose of 5 mg/ kg of bodyweight per day has to be respected.

Contra-indications, warnings, etc

Do not use in dogs with glaucoma

Do not use in case of hypersensitivity to Ephedrine or to any of the excipients.

Do not use the product in dogs under 20 kilogram of bodyweight.

This product is not suitable for treatment of inappropriate urination resulting of behaviour problems.

As ephedrine is an alpha and beta adrenergic receptor agonist, the product should be used with caution in dogs with cardiovascular disease and only after a comprehensive risk/benefit analysis by the attending veterinarian.

The dog’s cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment.

In addition, a similar approach should be adopted in animals suffering from partial urethral obstruction, hypertension, diabetes mellitus, hyperadrenocorticism, hyperthyroidism or other metabolic disorders. It should be mentioned that the Polyuria/Polydipsia (PU/PD) frequently accompanying the aforementioned conditions may be falsely diagnosed as urinary incontinence.

Adverse reactions

Cardiovascular effects like tachycardia, atrial fibrillation, stimulation of the heart activity and vasoconstriction.

Stimulation of the central nervous system leading to sleeplessness, excitation, anxiety and muscle tremors.

Panting

Mydriasis

Cystitis

Bronchodilatation and decrease of mucus release in the respiratory mucosal membranes.

Reduction of the motility and tone of the intestinal wall.

Due to the nature of Ephedrine the mentioned effects can occur at the recommended therapeutic dose, with anxiety and cardiovascular effects being the most prevalent. In 10% of the treatments, side effects have been observed in efficacy studies.

Operator warnings

Ephedrine hydrochloride could be toxic if ingested. Adverse effects may include insomnia and nervousness, dizziness, headache, increased blood pressure, increased sweating and nausea.

Ingestion may be fatal, especially in children. To avoid accidental ingestion, the product must be used and kept out of the reach of children. Always replace the cap securely after use.

In the event of accidental ingestion, most importantly by children, seek immediate medical attention showing the physician the package insert.

It is strongly recommended that pregnant women should wear gloves for administration.

Wash hands after administration.

Use during pregnancy, lactation or lay

The safety of the product has not been established during pregnancy and lactation.

Do not use during the pregnancy and lactation.

Do not use in breeding animals.

Interactions

Ephedrine may interact with other sympathomimetics.

Ephedrine may enhance glucocorticoid metabolism.

Concomitant use with MAO-inhibitors may cause hypertension.

Ephedrine can enhance the activity of products of the same class as Theophylline.

Volatile anaesthetics may enhance the sensitivity of the myocardium to the cardiovascular effects of Ephedrine.

Concomitant use with cardiac glycosides, Quinine and tricyclic antidepressants can cause arrhythmias.

Vascular constrictions can occur after concomitant treatment with ergot alkaloids and Oxytocin.

Substances leading to an increase in pH of the urine are able to prolong the excretion of ephedrine, whereas substances leading to a decrease in pH of the urine are able to accelerate the excretion of ephedrine.

Overdose

The signs of overdose resemble those of the adverse reactions as described above. In case of overdose, it is useful to accelerate excretion of ephedrine by acidification of the urine and enhanced diuresis.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

Do not store above 25 °C.

Store in the original container. Divided tablets should be returned to the original package and used in the subsequent dose. Close the cap to click.

Legal category

POM-V

Packaging Quantities

Further information

Ephedrine directly stimulates alpha- and beta-adrenergic receptors, present in all organ systems. It also stimulates the release of catecholamines from sympathetic neurons. Since Ephedrine passes the blood-brain barrier, it also induces effects that are mediated through the central nervous system.

Ephedrine specifically causes a contraction of the internal urethral sphincter muscles and a relaxation of the bladder muscles through a sympathicomimetic action on the adrenergic receptors.

Marketing Authorisation Holder (if different from distributor)

Ecuphar NV

Legeweg 157-I

8020 Oostkamp

Belgium

Marketing authorisation number

Vm 32742/4002.

GTIN (Global Trade Item No)

-

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